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015 - Outsourcing in China: How far can it go?

015 - Outsourcing in China: How far can it go?

FromCMC Live - Chemistry, Manufacturing & Controls


015 - Outsourcing in China: How far can it go?

FromCMC Live - Chemistry, Manufacturing & Controls

ratings:
Length:
34 minutes
Released:
Nov 13, 2020
Format:
Podcast episode

Description

What We Covered00:55 – Ed, Brian and Meranda welcome to the show David Blasingame who speaks to his extensive background as a process chemist as well as the advantages and disadvantages of manufacturing drugs in China  10:20 – The importance of person in-plant activity and the White Coat Effect  11:29 – David speaks to the issues he’s experienced with employee turnover  17:11 – Facts and myths about America’s dependence on medicine from China, overcoming communications issues and the process of dealing with CMOs  23:41 – David talks about the benefits of staying with the same drug substance manufacturer and expounds on the reasons why not every program is a fit for China  31:55 – Ed, Brian and Meranda thank David for joining the show  Tweetable Quotes“One of the key activities for any oversight of manufacturing and any CMO is person in-plant activities.” “You better make sure you have an easy to manage process…easily transferable, and you really do have to budget to have a presence on that floor. All these things have to be factored into your decision to move into China.”“If you’re looking for a commercial process that you might be able to take anywhere, I’m not necessarily sure that [China] is the place that you would go.” “We found it actually paid for itself in having somebody on staff who can speak the language because the communication style and the communication was very different than when we didn’t have one.”“I think if you’re planning on doing manufacturing in China, plan on being hands on.” Relevant LinksDesign Space InPharmatics - LinkedInDesign Space InPharmatics - TwitterEdward Narke on LinkedInDavid Blasingame on LinkedIn
Released:
Nov 13, 2020
Format:
Podcast episode

Titles in the series (27)

FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.